Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812509
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-03-16
Brief Title:
Efficacy and Safety of MW032 and Xgeva in Subjects With Bone Metastases From Solid Tumors
Sponsor:
Mabwell Shanghai Bioscience Co Ltd
Organization:
Mabwell Shanghai Bioscience Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Double-blind Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection MW032 and Denosumab Xgeva in Subjects With Bone Metastases From Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-center randomized double-blind parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva in patients with bone metastases from solid tumors
Detailed Description:
This is A multi-center randomized double-blind parallel controlled Phase III clinical trial
The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva in patients with bone metastases from solid tumors
The secondary objective are to evaluate the clinical safety and immunogenicity of MW032 and Xgeva in patients with bone metastases from solid tumors
The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva in patients with bone metastases from solid tumors
The secondary objective are to evaluate the clinical safety and immunogenicity of MW032 and Xgeva in patients with bone metastases from solid tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None